New drug gap - list of new drugs that have been listed in the US and not listed in China

On August 2nd, CDE organized a symposium on accelerating the review and approval of imported drugs. The meeting mentioned 'to accelerate the review and approval of some imported drugs' in an orderly manner, and listed the scope of application - Europe and America in the past ten years A new drug that is not listed in China on a daily basis, which is one of the 'rare diseases' or 'drugs that prevent serious life-threatening diseases'.

The author medicine Based on the Rubik's Cube database, the new drugs that have not been listed in China in the past 10 years have been sorted out for reference.

Exported from the United States Library of Medicine Rubik's Cube for nearly 10 years (2008/1/1-2018/7/27) The first US drug approved, the following varieties were excluded:

1) The US market status shows the variety of discontinue;

2) China's highest-scheduled 'listed' varieties;

3) China has requested the delisting of the variety;

4) Oxygen, purified water and other varieties.

Manual verification of possible problems with the above data.

According to statistics, among the new drugs approved in the United States in the past 10 years, 361 varieties (according to the generic name, including the new compound) are not listed in China, of which 287 are chemical drugs, accounting for 80%. These are not listed in China. , 35 drug Including rare disease indications, 148 generic names have been approved by the FDA.

In the past 10 years, the US has listed unlisted drugs in China.

Notes: 1) For the same molecule, compounds with different acid bases and bases are counted as two different common names, such as desvenlafaxine fumarate and desvenlafaxine succinate. The statistics are 2 results. 2) The solvate is not calculated by the common name. The darunavir hydrate is included in the previously approved darunavir ethanolate. 3) The chemical referred to in this article does not contain the chemically synthesized enzyme, insulin, Monoclonal antibody and other synthetic biological products.

Among the above varieties, 191 have no patent protection in China (no compound patents, or patents have expired), of which 63 varieties are eligible for priority review, and 12 varieties have rare disease indications.

US-listed China is not listed and has no patent protection in China

For these varieties that are not protected by patents in China, we sort them according to the sales data disclosed in the original company's financial report. Here we list the TOP10 varieties for your reference.